Implementing adaptive designs: Logistical and operational considerations

被引:43
作者
Quinlan, Judith A.
Krams, Michael
机构
[1] Adaptive Trials, Clinical Development, Collegeville, PA 19426
来源
DRUG INFORMATION JOURNAL | 2006年 / 40卷 / 04期
关键词
adaptive design; modeling; drug supply; electronic data capture;
D O I
10.1177/216847900604000409
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
The objective of this article is to support a logistical and operational feasibility analysis: given the research question and the environment in which we work, is it appropriate to consider an adaptive design, and are we sufficient well prepared to deploy successfully?
引用
收藏
页码:437 / 444
页数:8
相关论文
共 10 条
[1]  
[Anonymous], 2002, Data monitoring committees in clinical trials: A practical perspective
[2]  
Berry DA., 2003, CANC MED, V6, P465
[3]  
Committee for Medicinal Products for Human Use, 2005, GUID DAT MON COMM
[4]   Adaptive designs for dose-finding based on efficacy-toxicity response [J].
Dragalin, V ;
Fedorov, V .
JOURNAL OF STATISTICAL PLANNING AND INFERENCE, 2006, 136 (06) :1800-1823
[5]   Confidentiality and trial integrity issues for adaptive designs [J].
Gallo, Paul .
DRUG INFORMATION JOURNAL, 2006, 40 (04) :445-450
[6]   Adaptive dose-response studies [J].
Gaydos, Brenda ;
Krams, Michael ;
Perevozskaya, Inna ;
Bretz, Frank ;
Liu, Qing ;
Gallo, Paul ;
Berry, Don ;
Chuang-Stein, Christy ;
Pinheiro, Jose ;
Bedding, Alun .
DRUG INFORMATION JOURNAL, 2006, 40 (04) :451-461
[7]   ASTIN: a Bayesian adaptive dose-response trial in acute stroke [J].
Grieve, AP ;
Krams, M .
CLINICAL TRIALS, 2005, 2 (04) :340-351
[8]   Adaptive seamless phase II/III designs - Background, operational aspects, and examples [J].
Maca, Jeff ;
Bhattacharya, Suman ;
Dragalin, Vladimir ;
Gallo, Paul ;
Krams, Michael .
DRUG INFORMATION JOURNAL, 2006, 40 (04) :463-473
[9]   Dose-finding based on efficacy-toxicity trade-offs [J].
Thall, PF ;
Cook, JD .
BIOMETRICS, 2004, 60 (03) :684-693
[10]  
US Food and Drug Administration, 2006, GUID CLIN TRIAL SPON